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S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)

This study is currently recruiting participants.
Verified February 2012 by Second Military Medical University
Sponsor:
Information provided by (Responsible Party):
Xie feng, Second Military Medical University
ClinicalTrials.gov Identifier:
NCT01533324
First received: February 10, 2012
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good efficiency and safety in colorectal cancer (CRC). The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.


Condition Intervention Phase
Carcinoma
Liver Diseases
Hepatocellular Carcinoma
 Drug: S-1 combined with Leucovorin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Second Military Medical University:

Primary Outcome Measures:
  • DCR [ Time Frame: in two years ] [ Designated as safety issue: No ]
    DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1


Secondary Outcome Measures:
  • TTP ( time to progression) [ Time Frame: in 2 years ] [ Designated as safety issue: No ]
    from enrolled to progression(iconography).

  • OS ( overall survival) [ Time Frame: in two years ] [ Designated as safety issue: No ]
    to death

  • safety [ Time Frame: in two years ] [ Designated as safety issue: Yes ]
    any adverse reaction by NCI-CTCAE 3.0


Estimated Enrollment: 32
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-1 combined with LV
S-1 combined with LV
 Drug: S-1 combined with Leucovorin
S-1 capsules 80mg/m2/d BID one week on and one week off Leucovorin tablets 50mg/d BID one week on and one week off
Other Names:
  • TS-1
  • formyltetrahydrofolate

Detailed Description:

S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in HCC. S-1 combined with calcium folinate (SL) showed very good efficiency and safety in CRC. The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.

SL one week on and one week off regimen will be give to advanced HCC patients. The primary endpoint is durable complete response (DCR).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 70 years > Age > 18 years
  • Patient with unresectable primary hepatocellular carcinoma
  • Child-Pugh Class A or B, without ascites
  • ECOG score 0
  • At least one tumor nodule can be evaluated by CT or MRI
  • Can take medicine orally
  • Expected survival time not less than 12 weeks
  • Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study During the trial and 4 week after the trial, must take contraception
  • Patients must be:
  • Hemoglobin > 9.0g/dl
  • ANC > 1.5×109/L
  • Platelet ≥ 60×109/L
  • Total bilirubin < 3mg/dl
  • ALT or AST < 5 X ULN
  • ALP < 4 X ULN
  • PT-INR < 2.3
  • Patients who is taking Warfarin , should be tested every week till getting stable INR
  • Serum creatinine < 1.5 X ULN
  • Serum amylase and lipase < 2 X ULN

Exclusion Criteria:

  • Known or suspected allergy to any agent given in association with this trial
  • Local treatment within 4 weeks prior to start of study drug
  • History of any heart disease
  • History of HIV infection except for HBV and HCV
  • Active clinically serious infections (> 2 NCI-CTC Version 3.0)
  • Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
  • Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization within 6 months prior to study entry
  • Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1], early gastric cancer, or other malignancies curatively treated > 3 years prior to entry
  • Extrahepatic tumor spread which affects patient's prognosis, such as bony metastasis or brain metastasis
  • Hydrothorax， ascites and hydropericardium need to drain
  • Serious diarrhea
  • Combined with serious pulmonary diseases, such as interstitial pneumonia, pulmonary fibrosis and serious pulmonary emphysema
  • Serious complication,such as intestinal obstruction,renal insufficiency, hepatic insufficiency and cerebrovascular disorders
  • Pregnant or breast-feeding
  • Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
  • Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
  • Patients unable to swallow oral medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533324

Contacts
Contact: Xie Feng, physician +8613386272885 hunanxiefeng@yahoo.com.cn

Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Xie Feng, attending physician     +8613386272885     hunanxiefeng@yahoo.com.cn    
Principal Investigator: Xie Feng, attending physician            
Sponsors and Collaborators
Second Military Medical University
Investigators
Study Chair: Yang Jiamei, Chief the Second Military Medical University
  More Information

No publications provided

Responsible Party: Xie feng, attending physician, Second Military Medical University
ClinicalTrials.gov Identifier: NCT01533324     History of Changes
Other Study ID Numbers: HCC-SL-2W
Study First Received: February 10, 2012
Last Updated: February 14, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Second Military Medical University:
hepatocellular carcinoma
S-1
Leucovorin
fluorouracil

Additional relevant MeSH terms:
Carcinoma
Liver Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Formyltetrahydrofolates
Leucovorin
Levoleucovorin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013